Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-020.00 Effective date: mm/dd/yyyy
Approved by:
39.1 PurPose
To provide a guideline to perform an audit to ensure that abbreviated submissions to the FDA are
adequately supported and documented. Submissions subjected to this procedure include New Drug
Application, Abbreviated New Drug Applications and Supplements.
39.2 resPonsibility
All departmental managers are responsible for following the procedure.
39.3 instructions
Before a preinspection audit, department managers will make sure that all necessary documents as
per the procedure are approved, current, and are available at the point of use and in the master file.
39.4 Procedure
Check that the following are as per the given requirements.
39.4.1 t
echnical
d
ocumentS
Check that the following approved and current documents are available at the point of use and in the
master document file.
a. Raw material specifications with the test method (active and inactive)
b. Finished product specifications
c. Standard test methods
d. Packaging commodity specifications
e. Master manufacturing formula and method
f. Master packaging instructions
g. Validation master plans
h. Cleaning validation master plan
39.4.2 r
aw
and
P
ackaging
m
aterialS
a. The raw and packaging materials receiving log entry for each component will be checked
to ensure that
• Suficientquantitywasreceivedtojustifytheusageinthebatch.
• Thedatereceivedisconsistentwiththedateofusageinthebatch.
• Thevendorofthematerialisthesourceindicatedinthesubmission.
• MaterialmeetsalltherequirementsgivenintheSOP.
• CheckthatthematerialreceivingreportwaspreparedaspertheSOP.
• Checkthatrawmaterialwassampledandstoredaspertheprocedure.
b. The raw material inventory card for each component will be checked to ensure that
• Theamountenteredonthecardisconsistentwiththeusagerelectedonthebatch
record.
c. The following documentation will be collected for review.
• Foreachrawmaterial(activeorinactive)usedinthebatch:
• Therawmaterial/packagingmaterialreceivinglogentry.
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